Integrated Resources
Quality Assurance Associate II
Integrated Resources, Waltham, Massachusetts, United States, 02254
Job Title : Quality Assurance Associate IILocation: Waltham, MADuration: 12 moths +Pay range - $44 - $47/hr. on w2
Job Description:• Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities.• Perform QA review of Executed Batch Records.• Perform QA review of Quality Records, i.e. Deviations, CAPAs, OOS etc., as they occur.• Perform QA review and approval on SOPs, forms, WI, and other document types.• Provide SAP support for GMID and BOM approval.• Provide Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.• Ensure all requirements, stipulated in the CMO Quality Agreements, are being met.• Review and Approve Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments, if needed.• Participate in Quality Risk Assessments• Assist with internal and external audits.• Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested.• Assume additional responsibilities as assigned.
Competencies/ Requirements for positionQualifications/ Education & work experience• Bachelor's and/or 8+ years of relevant experience• Minimum 5 years of experience in Quality• Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably Producted from working in a manufacturing, QA or QC environment.• Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.• Must have excellent attention to detail, project and time management skills, and the ability tomanage multiple priorities with aggressive timelines.• Preferred experience with outsourced manufacturing and testing operations• Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
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Job Description:• Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities.• Perform QA review of Executed Batch Records.• Perform QA review of Quality Records, i.e. Deviations, CAPAs, OOS etc., as they occur.• Perform QA review and approval on SOPs, forms, WI, and other document types.• Provide SAP support for GMID and BOM approval.• Provide Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.• Ensure all requirements, stipulated in the CMO Quality Agreements, are being met.• Review and Approve Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments, if needed.• Participate in Quality Risk Assessments• Assist with internal and external audits.• Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested.• Assume additional responsibilities as assigned.
Competencies/ Requirements for positionQualifications/ Education & work experience• Bachelor's and/or 8+ years of relevant experience• Minimum 5 years of experience in Quality• Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably Producted from working in a manufacturing, QA or QC environment.• Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.• Must have excellent attention to detail, project and time management skills, and the ability tomanage multiple priorities with aggressive timelines.• Preferred experience with outsourced manufacturing and testing operations• Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
#sczr2